Entegee · 15 hours ago
Quality Engineer - Medical Device
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $110K/yr
5+ years expEntegee is a company specializing in medical devices, and they are seeking a Quality Assurance Engineer to support design transfer, supplier quality, validation, and manufacturing quality throughout the product lifecycle. The role involves collaborating with suppliers, R&D, and manufacturing teams to ensure compliance with quality and regulatory standards.
Information TechnologyStaffing Agency
Responsibilities
Work with suppliers, R&D, and manufacturing teams to meet quality and regulatory requirements throughout the product lifecycle
Support supplier oversight, including SCAR activities, nonconformance reviews, and rework evaluations
Manage supplier-related NCMRs, CAPAs, and complaint-driven corrective actions
Provide ongoing manufacturing support for process improvements and design updates moving into production
Assist in executing design transfer and maintaining manufacturing records such as DHRs, BOMs, routers, and specifications
Investigate and disposition product and material nonconformances; participate in MRB reviews and coordinate supplier corrective action
Review incoming inspection results and disposition components or subsystems as required
Assess process, equipment, and material changes to determine validation impact and define required validation work
Maintain and update risk management documentation in alignment with ISO 14971
Support the calibration program and associated documentation needs
Create, update, and maintain procedures, test methods, validation protocols, and technical reports
Document all activities in compliance with medical device regulatory and quality system standards
Lead investigations into quality issues, complaints, and audit findings; support CAPA development and implementation
Assist in onboarding and managing approved suppliers; take part in internal and external audits
Use root-cause analysis and structured problem-solving tools to drive corrections and prevent recurrence
Review and analyze quality metrics to identify trends and drive continuous improvement efforts
Qualification
Required
Bachelor's degree in Engineering
5–7 years of experience in medical device manufacturing and/or quality
Background supporting design transfer into production environments
Hands-on experience performing process validation activities
Familiarity with test method validation, Gage R&R, and measurement systems analysis
Knowledge of ISO 14971 risk management practices
Working understanding of 21 CFR Part 820 and ISO 13485 quality system expectations
Strong Microsoft Word and Excel skills
Preferred
Experience managing suppliers, including quality oversight and corrective action follow‑up
Proficiency with statistical software (e.g., Minitab)
Ability to apply advanced statistics (DOE, capability studies, ANOVA, tolerance intervals, sample size/power calculations)
Hands-on exposure to electromechanical assembly, ESD practices, cabling, cleanroom work, labeling, sterilization, or fiber-optic assembly
Experience writing and reviewing validation protocols and reports
Ability to assess quality data trends and identify improvement areas
Experience working within fast-paced or start‑up environments
Benefits
Medical
Dental
Vision
Term life insurance
Short-term disability insurance
Additional voluntary benefits
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Company
Entegee
Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
201-500 employees
H1B Sponsorship
Entegee has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Bob Bolster
Chief Operating Officer
Company data provided by crunchbase